Medication delivery device with gear set dosage system

ABSTRACT

A medication delivery device is disclosed including a rack-and-pinion plunger drive system. The drive system includes an output drive having a pawled end movably coupled with the ratchet teeth of the plunger, and a pinion drive coupled between the housing, the output drive and an actuator. Actuator is longitudinally movable between dose set and delivery positions. Movement of the actuator causes rotation of the pinion drive along the rack to translate the output drive member with the pawled end that is engaged with the plunger ratchet teeth to distally advance the plunger. The device may include one or more of an end of dose mechanism to limit travel of the actuator, a load brake system to stop travel of the plunger under high input forces, a dose detection system, and a dose selector to vary the amount of dose set.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 17/044,401, which is a National Stage application, filed under35 U.S.C. s. 371, of International Patent Application No.PCT/US2020/023514, filed on Mar. 19, 2020, which claims the benefit ofand priority to, under 35 U.S.C. § 119(e), U.S. Provisional ApplicationSer. No. 62/826,232, filed on Mar. 29, 2019, all which are herebyincorporated herein by reference in their entirety for all that itteaches and for all purposes.

BACKGROUND

The present disclosure pertains to medication dispensing devices, and,in particular, to a portable medication dispensing device such as aninjector pen.

Patients suffering from a number of different diseases frequently mustinject themselves with medication. To allow a person to conveniently andaccurately self-administer medicine, a variety of devices broadly knownas injector pens or injection pens have been developed. Generally, thesepens are equipped with a cartridge including a piston and containing amulti-dose quantity of liquid medication. A drive member, extending fromwithin a base of the injector pen and operably connected with typicallymore rearward mechanisms of the pen that control drive member motion, ismovable forward to advance the piston in the cartridge in such a mannerto dispense the contained medication from an outlet at the oppositecartridge end, typically through a needle that penetrates a stopper atthat opposite end. In disposable pens, after a pen has been utilized toexhaust the supply of medication within the cartridge, the entire pen isdiscarded by a user, who then begins using a new replacement pen. Inreusable pens, after a pen has been utilized to exhaust the supply ofmedication within the cartridge, the pen is disassembled to allowreplacement of the spent cartridge with a fresh cartridge, and then thepen is reassembled for its subsequent use.

It would be desirable to provide a medication dispensing device withimproved features, such as accommodating differently sized doses or adose detection sensing system that can overcome one or more of these andother shortcomings of the prior art.

SUMMARY

A medication delivery device including a housing including one or morehousing rack teeth, a plunger to drive a piston disposed within amedication cartridge barrel, the plunger body including a plurality ofratchet teeth; and a plunger drive system configured to distally advancethe plunger. The plunger drive system includes an output drive memberhaving one or more pawled ends movably coupled with the ratchet teeth ofthe plunger. At least one pinion drive is engaged with the drive teethof the output drive member and the housing rack teeth of the housing. Anactuator is coupled to the at least one pinion drive. In one embodiment,the actuator has a unitary piece body extending between a button end andthe coupling end disposed within the housing. The actuator islongitudinally movable between an extended position for dose setting anda retracted position for dose delivery. In response to movement of theactuator to the extended position from the retracted position, rotationof the at least one pinion drive in a first direction along the driveteeth is configured to axially translate the output drive memberrelative to the plunger, with the one or more pawled ends of the outputdrive member sliding along the ratchet teeth of the plunger. In responseto movement of the actuator to the retracted position from the extendedposition, rotation of the at least one pinion drive in a seconddirection along the drive teeth is configured to axially translate theoutput drive member, with the one or more pawled ends of the outputdrive member in engagement with the ratchet teeth of the plunger toprevent the output drive member from translating axially relative to theplunger, thereby advancing the plunger in a distal direction. In oneembodiment, a dose selector may be included to allow variation of thedose set by the actuator. In one embodiment, a dose detection sensorsystem may be incorporated to detect, determine, display and/orcommunicate the detected dose to an external control system. In oneembodiment, the actuator may also include a load brake system.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other advantages and objects of this invention,and the manner of attaining them, will become more apparent, and theinvention itself will be better understood, by reference to thefollowing description of embodiments of the invention taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an example of a delivery device;

FIG. 2 is an exploded part perspective view of the delivery device inFIG. 1;

FIGS. 3-4 are perspective views of each of the device housing halves,respectively.

FIGS. 5-6 are each different perspective views of an example of aplunger.

FIGS. 5a-6a are each different perspective views of another example of aplunger.

FIGS. 7-9 depict sequential operational steps of an example plungerdrive system in the delivery device in FIG. 1.

FIGS. 10-11 are each different perspective views of an example of anoutput drive element in a plunger drive system.

FIGS. 10a-11a are each different perspective views of another example ofan output drive element in a plunger drive system.

FIGS. 12-14 are each different perspective views of an example of anactuator in a plunger drive system.

FIGS. 15-16 are perspective views of each of the pinion drive elements,respectively.

FIGS. 15A-16A are perspective views of each of the pinion driveelements, respectively.

FIG. 17 is a perspective view of an assembly of the pinion driveelements, the output drive element, and the plunger in a plunger drivesystem.

FIGS. 18-19 depict sequential operational steps of an example plungerdrive system in the delivery device in FIG. 1.

FIG. 20 depicts operation of the device components when there isinsufficient remaining dose left in the delivery device.

FIG. 21 is an exploded part perspective view of a dose knob with a doseselector feature.

FIG. 22 is a perspective view of a proximal end of the delivery devicein FIG. 1.

FIG. 23 is a cross-sectional view of a proximal end of the deliverydevice in FIG. 1.

FIG. 24 is a cross-sectional view of a proximal portion of the deliverydevice in FIG. 1, depicting the arrangement of one example of a dosedetection system.

FIG. 25 is a perspective view of one example of an electronics assemblyof the dose detection system.

FIG. 26 is a block-diagram illustration of a medication delivery devicecommunicating data to a remote device.

FIG. 27 is an exploded part perspective view of another example of amedication delivery device including a dose detection system.

FIG. 28 is a front view of the medication delivery device of FIG. 27prior to delivering a dose of medication and with a cap and a frontdistal housing piece removed.

FIG. 29 is a front view of the medication delivery device of FIG. 27during a dose delivery operation with a cap and a front distal housingpiece removed.

FIGS. 30a-30b are opposite end perspective views of a plunger member ofthe medication delivery device of FIG. 27.

Corresponding reference characters indicate corresponding partsthroughout the several views. Although the drawings representembodiments of the present invention, the drawings are not necessarilyto scale, and certain features may be exaggerated or omitted in some ofthe drawings in order to better illustrate and explain the presentinvention.

DETAILED DESCRIPTION

The shown device in FIG. 1 is an example of a pen-shaped medicationinjection device, generally designated 20, which is manually handled bya user to selectively set a dose and then to inject that set dose. Inone example, device 20 may include a dose detection sensing system. Thesensing system can be adapted for use in variously configured medicationdelivery devices, including differently constructed pen-shapedmedication injection devices, differently shaped injection devices, andinfusion devices. Any directional references in this detaileddescription with respect to FIG. 1 or any of the other Figures, such asright or left, up or down, or top or bottom, are intended forconvenience of description, and by itself does not limit the presentdisclosure or any of its components to any particular positional orspatial orientation. When used, the term “distal” and “proximal” areused relative to the user and actuator button, and generally, during apatient's use of the device, the distal end, such as the needle end,would be closest in proximity to the patient, and the proximal end,opposite the distal end, would be farther in proximity from the patient.

Device 20 is shown including an elongated cylinder-like housing 21disposed about a longitudinal axis AA, although other forms are withinthe scope of the disclosure. Device 20 may be disposable, in that afterthe quantity of medicine contained therein is exhausted by multipleoperations of the device, the entire device is discarded rather thanbeing reset and reloaded with a replacement container of medicine.Device 20 may be repeatably operable to deliver into a user a fixeddose, i.e., a dose in a specific amount that is dictated by theparticular design of the device and that may not be changed withoutredesigning the device. Alternatively, device 20 may be configurable bya user, manufacturer, pharmacist, or health care provider to repeatablydeliver one of multiple different dose sizes. In some embodiments, thedevice 20 may be configured to allow the manufacturer, pharmacist, orhealth care provider to set the dose size, but to prevent the user frommodifying the dose size once set.

Device 20 generally includes a distal portion 22 and a proximal portion24. Distal portion 22 contains the medicinal fluid to be outlet at itsdistal end upon pen operation. The outlet end of distal portion 22 isconfigured to receive an injection needle (not shown), when device is inan uncapped state. A cap 36 for the pen may be provided. Cap 36 may besized to fit the device with or without a needle. Proximal portion 24contains the injecting mechanism used to force the contained medicinefrom the needled end.

The device housing 21 may be formed from a lightweight material, such asinjection molded plastic, in a single or multiple piece construction.Housing 21 is shown having two longitudinally extending halves 30 and31, as shown in FIGS. 2-4. The housing halves 30 and 31 are aligned viamating pins and recesses provided therein and fixedly secured togetherduring manufacture, such as via adhesives or ultrasonic welding. Thedevice housing 21 defines an internal hollow 32 in which an axiallyadvanceable plunger drive system, generally designated 60, extends atleast generally along the longitudinal axis.

With additional reference to FIG. 2, distal portion 22 may include atubular cartridge retainer 34 configured to hold a cartridge 48. Thecartridge retainer 34 is shown as a discrete component that is coupledto the housing or may be formed in part as a distal extension of thehousing 21. Retainer 34 may include a step-down distal end 35 configuredfor releasably coupling to the needle assembly. In one example, theretainer end 35 is configured for threaded engagement with the needleassembly. The proximal end 37 of the retainer 34 may define acylindrical extension for coupling to the device housing 21.

The needle assembly (not shown) may include a double-ended needlecannula or injection needle having a distal tip at one end and aproximal point at the other. The injection needle includes a tubular hubthat is configured for threaded engagement with retainer end 35 so as tobe screwable onto and off of the threading of the retainer end. Othertypes of connection types, including a snap on connection, may beprovided between the needle assembly and the cartridge retainer. Thedistal tip may be protected by a tubular shield coupled to the hub, aswell as, a device cap 36 that is releasably attachable to, for example,the device housing 21, which the device cap 36 and/or shield is removedwhen device 20 is used to inject medicine. Needle assemblies which maybe used with device 20 may include assemblies with one or more shortenedinjection needles.

Cartridge 48 defines a medicine-filled reservoir 50 that is closed atits proximal end by a piston 52 that is axially slidably and sealablyengaged with the cartridge interior wall to hold the fluid medicationwithin reservoir 50. The distal, outlet end 53 of cartridge reservoir 50is sealed by a septum 54, shown generally at end 53. When the needleassembly is mounted to retainer end 35, the proximal point of theinjection needle penetrates the cartridge septum 54 to provide a fluidflow path by which medicine within cartridge reservoir 50 can bedispensed from the needle tip during operation of device 20. Cartridge48 is sandwiched between the interior surface of retainer 34, with itsproximal end contacting an internal bulkhead 44 provided on housinghalves 30 and 31, as shown in FIG. 24, to prevent axial movement of thecartridge during use. Other manners of capturing the cartridge relativeto the housing may alternatively be employed.

Device 20 may further comprise a medication, such as in cartridge 48. Inanother embodiment, a system may comprise one or more devices includingdevice 20 and a medication. The term “medication” refers to one or moretherapeutic agents including but not limited to insulins, insulinanalogs such as insulin lispro or insulin glargine, insulin derivatives,GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon,glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide(GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs,oxyntomodulin derivatives, therapeutic antibodies and any therapeuticagent that is capable of delivery by the above device. The medication asused in the device may be formulated with one or more excipients. Thedevice is operated in a manner generally as described above by apatient, caregiver or healthcare professional to deliver medication to aperson.

The interior surfaces of housing halves 30 and 31, respectively, areshown in FIGS. 3-4 formed with a variety of ribs and bulkheads thatserve to maintain the alignment and guide the motion of the apparatuscomponents disposed within housing 21. Housing halves 30 and 31 includedistally projecting, curved flanges 57, 59, respectively. Duringmanufacture, to mount the cartridge to the assembled housing, flanges57, 59 are first coupled to the retainer proximal end 37, such as beinginserted externally around or inside of the proximal end of retainer,and then fixedly secured to the retainer, such as via adhesives orultrasonic welding. When retainer 34 and housing 21 are so secured,cartridge 48 is axially sandwiched. The proximal end of housing 21defines at least partially a proximal end wall 46. The portion of thehousing 21 adjacent the proximal end wall 46 may have a reducedcross-sectional area that is configured to receive a rotatable knob 56,as shown in FIGS. 2 and 24.

With reference to FIG. 2, and FIGS. 5-16, proximal portion 24 of device20 includes the plunger drive system 60, which includes a gear setgenerally designated 62, a plunger member generally designated 64, anoutput drive element 68, and an actuator 90. Gear set 62 includes one ortwo pinion drive elements, shown as a pair 66, 67, and output driveelement 68 that are operatively cooperative to distally advance theplunger member 64. The plunger, output drive element, and gear setcomponents may each be injection molded in a single piece from a polymeror plastic material.

With additional reference to FIGS. 5-7, plunger member 64 has arectangular rod-shaped body that extends in the axial direction betweena proximal end 70, and a load distributing, disc-shaped foot 72 formedat the distal end 71 of the body of the plunger member 64 to engage thepiston 52. Foot 72 has a larger cross-sectional area than the transversecross-sectional area of general body of the plunger member 64 todistribute loading on the cartridge piston 52 during piston advancing.

The drive member components are constrained by the internal shaping ofhousing halves 30 and 31 to be axially translatable therein. Plungermember 64 is movable in the distal direction and prevented from proximalmovement relative to the housing 21, while output element 68 isclutchably connected to plunger member 64 to be moveable relativethereto in a proximal direction but not the distal direction. To providefor these one-way axial motions, ratchets are employed in the shownembodiment, but other elements may be used. For example, a hard butcompliant toothed member or members, such as made of metal, may beprovided in tight engagement with a smooth, such as cylindrical, andrelatively soft member lacking surface features, which metal tooth/teethare arranged such that motion of the other member in only a singledirection is permitted, as in the opposite direction the tooth/teeth diginto and deform the relatively soft surface to create a wedging actionthat impedes further motion in that direction.

In one example, body of plunger member 64 includes a row of one-wayramping ratchet teeth 74 on two oppositely facing sides 75, 77 of itsbody, which teeth 74 continue uninterrupted along a portion of the axiallength of the body. Other examples of a plunger may include a singleside of ratchet teeth. The axial positioning and length that each row ofteeth can span along its respective side is a function of various pawls'positioning and intended use, such as the total injection volume andnumber of discrete injections of device 20, as discussed in furtherdetail below. Teeth 74 are axially spaced from one another tocorresponding to a desired fixed dose per one or more teeth, which alsocorrelates a dose per a number of clicks, such as a dose per a singleclick, a dose per 2 clicks, etc. FIGS. 5-6 illustrate relatively closerspacing of teeth 74 for the plunger member 64 configured for a smallerdose, such as, for example, 100 microliters-per-click. A click isgenerated during advancement of the plunger member 64 by one tooth 74passed the fixed pawls 76. FIGS. 5A and-6A illustrate spacing betweenteeth 74 a that is larger relative to teeth 74 for the plunger member 64a configured for a larger dose, such as, for example, 250microliters-per-click. Plunger 64 a is shown being capable of having allof the features of plunger 64. Ratchet teeth 74 are engaged by a pair ofdiametrically opposed, resilient housing tabs or pawls 76 (see FIG. 4)fixed and integrally formed with housing half 31. As further shown inFIGS. 7-9, pawls 76 slide along and over teeth 74 when plunger member 64is advanced distally during use, but abut the transverse, proximal faceof teeth 74 to prevent plunger member 64 from backing up in the proximaldirection.

With additional reference to FIGS. 10-11, output drive element 68includes a pair of diametrically-opposed resilient pawls 78, disposedproximal to the fixed housing pawls 76 when output drive element 68 isretracted proximally, to also engage the same rows of ratchet teeth 74on opposite sides 75, 77 of body of plunger member 64. With reference toFIGS. 7-9, when drive element 68 is moved distally, the pawls 78 movesin the distal direction beyond the fixed housing pawls 76 to providecertainty that fixed pawls 76 have clicked over the ratchet teeth of theplunger member. As shown in FIG. 9. Pawls 78 and fixed pawls 76 are eachdisposed along a different surface portion of the ratchet tooth 74. Forexample, Pawls 78 engage an upper portion of the ratchet tooth, andfixed pawl 76 engage a lower portion of the ratchet teeth such that,when pawls 78 move past fixed pawls 76, the fixed pawls 78 areunderneath the pawls 76. If the pawls 78 do not move past the fixedpawls 76, then the ratchet of plunger member 64 may back up the nexttime a dose is set, which may lead to an incorrect dose. To insureclick-over occurs (i.e., to insure that fixed pawls 76 have clicked overthe correct number of ratchet teeth 74 at the end of a dose), theend-of-travel position of pawls 78 is distal to the fixed position ofpawls 76 by a distance called the “click-over margin.” For a plungerwith a single side of ratchet teeth described above, the output driveelement may include a single pawl. Output pawls 78 slide along and overone or more teeth 74 when output drive element 68 is retractedproximally during device cocking, but in abutment engagement with atleast one of teeth 74 during the distal advancement of output driveelement 68 during injection. As the pawls 78 slide over the teeth 74,clicking sounds may be generated during dose setting. The abuttingresults in output drive element 68 shifting the plunger member 64 in thedistal direction until end of travel. The pitch or distance between thetransverse face of each adjacent tooth 74 may be the distance piston 52needs to be advanced to deliver a fixed dose as predetermined by themanufacturer.

Output drive element 68 is shown having a U-shaped body 80 with a pairof longitudinally extending parallel, opposite facing sides 81, 83interconnected by a third side 85, transversing the sides 81, 83, todefine a plunger member receiving passage 87. A longitudinally extendingfirst rack of teeth 82 projects from one side 81 of body 80, and alongitudinally extending second rack of teeth 84 projects from theopposite side 83 of body 80. The body 80 is sized to fit over the bodyof plunger member 64. To this end, when coupled, the body of plungermember 64 is received axially within passage 87 of the body 80 such thatthe sides 81, 83 are in a confronting, overlapping relationship with theteeth sides 75, 77 of the plunger member 64 and the third side 85 is ina confronting overlapping relationship with a non-toothed side 91 of thebody of plunger member 64. The non-toothed side 91 may interconnect thesides 75, 77 of the plunger body. In this arrangement, the pawls 78 arenow engageable with the teeth 74 of the plunger member 64. The pawls 78may extend from the distal surface of the sides 81, 83.

A mechanical feature may be included to prevent operation of the devicewhen there is insufficient remaining dose (IRD) within the cartridge 48with an IRD arrangement. In the example shown, the third side 85includes a distal extension 88 extending beyond the racks 82, 84. Thedistal extension 88 is shown disposed between the pawls 78. The distalextension 88 may include an IRD tab 89 extending from the interiorsurface of the distal extension 88 in the space defined between thepawls 78. The IRD tab 89 is configured to fit within an IRD slot 93defined in the non-toothed side 91 of the member 64, with the IRD tab 89and slot 93 defining the IRD arrangement. The IRD slot 93 extendsbetween the foot 72 and the proximal end 70. A physical stop lip 95 isdefined by the plunger member 64 toward the proximal end 70 and isconfigured to contact the IRD tab to physically prevent further movementof the output drive element, and thus further proximal withdrawal of theactuator 90 (discussed below) during dose setting, indicating that thereis an insufficient remaining dose. FIGS. 10-11 illustrate the lowerlocation and number of rack of teeth 82, 84 for the output drive element68 configured for a smaller dose, such as, for example, 100microliters-per-click, for use with the plunger member 68 shown in FIGS.5-6. FIGS. 10A-11A illustrate the relatively upper location and fewernumber of rack of teeth 82 a, 84 a for the output drive element 68 aconfigured for a larger dose, such as, for example, 250microliters-per-click, for use with the plunger member 68 a shown inFIGS. 5A-6A. Output drive element 68 a is shown being capable of havingall of the features of output drive element 68 a.

Actuator 90 extendable proximally beyond the housing 21 of device 20 isprovided to allow a user to operate the internal gear set of theapparatus to prepare device 20 for injection, by withdrawing theactuator in the proximal direction from the device housing to anextended dose set configuration from a retracted configuration, as wellas to perform the injection by pushing the actuator in the distaldirection from the extended configuration to the retracted dosedelivered configuration. In FIG. 2, actuator 90 includes an axiallyextending body extending between an input end 92 and a button end 94.Although not shown, a spring coupled between the actuator and thehousing may be included for biasing the actuator towards a predefinedposition, such as the retracted position, and/or to dampen the movementof the actuator.

With reference to FIGS. 12-14, the button end 94 of actuator 90 includesan enlarged cross-sectional button 198, when compared to the remainingbody, upon which the user applies an actuation input force. At the inputend 92, the actuator includes a pinion-coupling feature configured tocouple to the pinion drive elements. For example, the actuator 90includes a first side 96 with a first pinion-coupling feature 100A,shown as slot 102 defined into the first side 96 with slot-definingwalls that are sized and configured to receive a firstlaterally-extended pin 104 defined by the first pinion drive element 66.When the actuator 90 includes a second side 98, opposite of the firstside 96, with a second pinion-coupling feature 100B, shown as slot 106defined into the second side 98 with slot-defining walls that are sizedand configured to receive a second laterally-extended pin 108 defined bythe second pinion drive element 67. The pinion coupling feature betweenthe actuator and the pinion drive element may include otherconfigurations, such as the actuator including an upper internal slot toreceive a pin rod extending between the confronting faces of both of thepinion drive elements, from the upper end or lower end, or a pinconfiguration to be received by slots defined in the pinion driveelements.

The actuator 90 may include a guide rail element 110 for interfacingwith the housing and/or or components to control the axial movement ofthe actuator. Guide rail element 110 extends axially away from thebutton end 94, and may be disposed extending axially between the firstand second sides 96, 98. The distal end 112 of the guide rail element110 may extend distally beyond the distal ends of the first and secondsides 96, 98, including extending distally beyond the slots 102, 106.The upper end 114 of the guide rail element 110 may extend radiallybeyond the walls defining the slots 102, 106 of the first and secondsides 96, 98, respectively. Axially extending upper end 114 has amaterial thickness that is sized to fit within and be slidably disposedbetween a pair of axially extending parallel guide ribs 116 dependingfrom an interior surface 117 of housing half 30 (see FIG. 3 and FIG.23). The axially extending lower end 118, opposite the upper end 114,has a material thickness that is sized to fit within and be slidablydisposed between a pair of axially extending parallel guide ribs 120extending away from the third side 85 of output drive element 68 (seeFIG. 10). A shelf 122 may extend laterally from one or both sides of theguide rail element 110. The shelf 122 may be disposed in between theupper end 114 and lower end 118 of the rail 110 at a desired distance toset the depth of the penetration of the shelf 122 into the space betweenthe ribs 120 and to stabilize the sliding of actuator 90 along the uppersurface of ribs 120, as shown in FIGS. 18-19. In other embodiments, itis the actuator that defines the guide ribs and a guide rail of theoutput member resides within the guide ribs. The guide rail element 110may define the rigid portion of the actuator body.

The gear set 62 utilized in device 20 is configured to convert actuatormotion of a first axial distance into drive member motion of a secondaxial distance less than the first distance. The first and second piniondrive elements 66, 67 of gear set 62 can be made from a lightweightmaterial such as plastic. Each of pinion drive elements 66, 67 arecoupled between the housing 21, such as, for example, housing half 31,the output drive element 68 and the actuator 90.

Pinion drive elements 66, 67 may be similarly configured. FIG. 15depicts one side of pinion drive element 66 and FIG. 16 depicts one sideof pinion drive element 67 from different perspectives, and for theopposite sides of the respective pinion drive elements 66, 67 that arehidden. In other words, FIG. 16 and FIG. 15 may be used to depict thehidden sides for pinion drive elements 66, 67, respectively. Piniondrive element 66 includes a first or larger sized pinion 130A thatincludes an arcuate section of external gear teeth 132A that mesh withteeth of a first rack 134A, shown located by dashed line in FIG. 4,defined by the housing half 31 of housing 21. Pinion drive elements 67includes a first or larger sized pinion 130B that includes an arcuatesection of external gear teeth 132B that mesh with teeth of a secondrack 134B defined in the housing half 31 of housing 21. The teeth ofracks 134A, 134B, respectively, are shown in FIG. 4, disposed from theinterior surface of the housing half 31 spaced from one another in aparallel relationship. An arcuate section of gear teeth is all that isrequired due to the small angle of revolution, such as, for example,approximately 90 degrees plus or minus five degrees of revolution angleor roll, of the pinion necessary for use of the shown pen, which smallangle or partial roll is possible due to the nominal range of 1.5:1 to6:1 mechanical advantage provided by the shown gear ratio. Other gearratios may be configured for desirable mechanical advantage less orgreater than the above-referenced nominal range.

Pinion drive element 66 includes a second or smaller sized pinion 136Athat includes an arcuate section of external gear teeth 138A that meshwith the teeth of second rack 84 of output drive element 68. Piniondrive element 67 includes a second or smaller sized pinion 136B thatincludes an arcuate section of external gear teeth 138B that mesh withthe teeth of first rack 82 of output drive element 68. Each of thesmaller sized pinions 136A, 136B has the same axis of rotation RA as thecorresponding larger-sized pinions 130A, 130B of the respective piniondrive element. Gear teeth 138A, 138B may have a pitch diameter that isless than the pitch diameter of the corresponding gear teeth 132A, 132B.In the shown embodiment, such diameter is in a range of about 70 to 80%of the diameter of gear teeth, which ratio provides the nominally 4 to 6to one mechanical advantage. Smaller ratios may be employed, such asdown in the range of 40 to 50%, which realizes a 1.5 to two to onemechanical advantage, and larger ratios may alternatively be employed,such as realizing a ratio for a sixteen to one mechanical advantage. Thesize and/or number of teeth and racks of the housing, pinions and theoutput drive element provide a mechanical advantage structure that canvary its mechanical advantage depending on the relative sizes. Althougheach of pinion 130A, 130B and corresponding pinion 136A, 136B can beintegrally formed, these components can be separately formed andassembled together. Pin 104 or 108 is located at such axis RA and isshown integrally formed with the pinions. Each of pins 104, 108 is sizedand shaped to fit into, and pivot or partially rotate within, therespective slot 102, 106 defined in actuator 90 during use. In otherembodiments, the coupling between the pinion drive elements and theoutput drive element is not a rack/pinion arrangement. For example, eachof the pinion drive elements may include a pin inserted withincorresponding slots defined in the outer sides of the output driveelement. In another example, each of the pinion drive elements mayinclude one or more cammed surfaces for rolling engagement withcorresponding one or more pins extending outward from the sides of theoutput drive element. In another example, each of the pinion driveelements may include a protruding non circular tooth inserted withincorresponding slot defined by the sides of the output drive element. Inanother example, each of the pinion drive elements may define a slot forreceiving corresponding oblong tooth extending outward from the sides ofthe output drive element. FIGS. 15-16 illustrate the lower radiallocation (farther from radial axis RA) and higher number of pinion teeth138A, 138B for the pinions 66, 67, respectively, configured for asmaller dose, such as, for example, 100 microliters-per-click, for usewith the output drive element 68 and plunger member 64. FIGS. 15A-16Aillustrate the relatively upper radial location (closer in proximity tothe radial axis RA) and fewer number of pinion teeth 138A′, 138B′ forpinions 66A, 67A, respectively, configured for a larger dose, such as,for example, 250 microliters-per-click, for use with the output driveelement 68 a and plunger member 64 a. Pinions 66A, 67A are shown beingcapable of having all of the features of pinions 66, 67.

FIG. 17 illustrates the rolling interaction of the larger sized pinionof pinion drive elements 66, 67 with the fixed racks (rack 134B shown)of the housing half 31, and the rolling interaction of the smaller sizedpinion of pinion drive elements 66, 67 with the respective racks 82, 84or 82 a, 84 a of output drive element 68 or 68 a, that are obstructedfrom view by the pinions, to advance the plunger member 64.

FIGS. 18-19, as well as FIGS. 7-9, illustrate the operation of thedevice 20, with some components omitted to bring clarity to theinternals of the device. For example, the device shown in FIG. 18 iswith actuator 90 in its retracted position, which in this position thedevice is ready to be set or the dose has been delivered. FIG. 7illustrates the position of the distal end of the output drive element68 in relation to the plunger member 64 when the actuator is in itsretracted position. When a lock is employed, such as, for example, withthe knob 56, to prevent inadvertent dose setting of the actuator, theuser will unlock the device. The user applies a force in the proximaldirection (shown by arrow 140) to the actuator 90 to withdraw theactuator from its retracted position to allow positioning of piniondrive elements 66, 67 of the gear set 62 and thus the rack and pinioncoupling of the output drive element 68 to move element 68, as depictedby arrow 142, axially in the proximal direction over the plunger member64 that remains stationary. FIG. 8 illustrates the position of thedistal end of the output drive element 68 in relation to the plungermember 64 when the actuator is being withdrawn in the proximal directionshow by the arrow 149 from its retracted position. The housing pawls 76are in abutment engagement with the ratchet teeth 74 to prevent theplunger member 64 from moving in the proximal direction, while element68 is in movement. This relative movement between output drive element68 and plunger member 64 is enabled by the ability of the pawls 78 onoutput element 68 to slidably move over the ratchet teeth 74 of theplunger member 64 in the proximal direction. The device shown in FIG. 19is with actuator 90 in its extended dose set configuration, which inthis position the actuator has been withdrawn to perform the injection.The user applies a force in the distal direction (shown by arrow 144)against the actuator 90 to push the actuator to its retracted positionto allow actuation of pinion drive elements 66, 67 of the gear set 62and thus the rack and pinion coupling of the output drive element 68 toadvance element 68 together with the plunger member 64 in the distaldirection, as shown by arrow 146. This movement is from engagement ofthe pawls 78 against the ratchet teeth 74 that prevents the plungermember 64 from moving axially in the proximal direction relative to theoutput drive element 68. FIG. 9 illustrates the position of the distalend of the output drive element 68 in relation to the plunger member 64when the actuator is pushed all the way in in the distal direction shownby the arrow 147 from its extended position to distally advance theplunger member for dose delivery.

FIG. 20 illustrates that the devices described herein may be preventedfrom complete operation when there is insufficient remaining dose byinhibiting the actuator 90 from being withdrawn. The output driveelement 68 is shown being unable to move any further in the proximaldirection relative to the plunger 64 by the IRD tab 89 that is slidablydisposed within the IRD slot 93 by engaging the stop lip 95 of theplunger member 64 to set the IRD arrangement, as shown in FIG. 20. Priorto reaching the stop position, the output drive element 68 is able tomove relative to the plunger member 64 as the IRD tab 89 slidably moveswithin the IRD slot 93 as shown in FIG. 9. The IRD arrangement may setduring dose setting to inhibit the user from achieving the desired dose.For example, the IRD arrangement will prevent the dose setting of adesired dose units associated with 2 clicks, with the setting of the IRDarrangement after a single click, falling one click short of the desireddose. To this end, the user may need another device for delivery of theremaining dose.

In FIGS. 21-22, knob 56 includes a cylindrical body 150 sized to fitsurrounding the proximal end of housing 21. The knob 56 may include aninternal radial lip 152 for engagement with the housing end once the endof housing 21 is inserted within the knob body 150 during assembly. Theknob 56 may be rotated to a lock position, shown in FIG. 18. Otherconfigurations to lock the actuator may be utilized. Knob 56, when inits locked position, prevents the actuator 90 from being moved for dosesetting. Only when rotated to an unlocked position, shown in FIG. 19,can the user withdraw the actuator 90 to set the dose. In one example,with additional reference to FIG. 12, the actuator 90 includes aninterlock stop protrusion 158 disposed along the upper end 114 of therail 110 of the actuator 90. The interlock stop protrusion 158 may bedefined as a stepped region 160 of the rail 110, where the elevation ofthe interlock stop protrusion and stepped region 160 is above anadjacent recessed region 162 that is proximal to the interlock stopprotrusion 158. At its locked position, a region 164 of the internal lip152 of knob 56 is positioned across the travel path of the interlockstop protrusion 158, physically blocking the actuator 90 from fartherproximal travel. At its unlocked position, a slotted region, showngenerally as 166, of the internal lip 152 is positioned across thetravel path of the interlock stop protrusion 158 to permit the actuator90 to proximally travel for dose setting. The slotted region 166 issized to receive and allow the passage of the interlock stop protrusion158 and stepped region 160 therethrough.

One aspect of the devices described herein is their ability to deliver afixed volume of dose a single time, if so configured, or a fixed volumeof dose repeatedly multiple times. In one embodiment of the device, itmay be desirable for a user or health care provide to vary the volume ofthe fixed dose during treatment, such as, for example, during atitration routine. To this end, the device 20 may include a doseselector 170 that is configured to limit the travel of the actuator 90during dose setting to a position less than full travel corresponding to100% of the fixed dose volume for a single injection. The dose selector170 may be movable between at least two positions or more than twopositions when the device is configured for more than two settings. Whenthe dose selector 170 is in a first position, the actuator 90 is allowedto travel the full distance to permit a fixed dose volume of 100%. Whenthe dose selector 170 is in a second position, the actuator 90 isallowed to travel less than the distance to permit delivery of a fixeddose volume of something less than 100%. The dose selector 170 may beincluded in any part of the device. In one example, the dose selector170 in at least one of its positions engages the actuator 90 to inhibitthe travel of the actuator to its 100% dose position. In one example,the dose selector 170 includes a portion that is contactable by the userso that the user can apply a force to the dose selector to shift toanother position. In one example, the device 20 may include a doseindicator 172 to indicate to the user which dose is being selected bythe dose selector and/or to indicate the locked position.

The knob body 150 and the indicator 172 may be integrally formed into asingle piece. In FIG. 21, the knob body 150 may have a clam shell designto facilitate assembly to the device housing. The indicator 172 may be aseparate piece that couples to the body 150. For example, the knob body150 is shown with a pair of external coupling axial lips 174 disposedalong the slot 175 of the knob body 150, and the indicator 172 has abody 178 to fit over the lips 174 in an interference fit. As shown inFIG. 22, the proximal end of the indicator 178 may include a pointerelement 180 that overlaps the proximal end wall 46 of the device housing21. The proximal end wall 46 may have markings, debossments,embossments, stickers, or other indications, shown generally as 182, towhich the pointer element 180 is associated with to indicate the size ofthe fixed dose when the knob 56 is rotated.

FIG. 21-22 illustrates one example of the dose selector 170 of thedevice. Here, the dose selector 170 is defined by the knob 56 thatincludes slotted regions and/or one or more axial tangs. When more thanone tangs 185 are provided, the tangs 185 are circumferentially disposedrelative to one another. Each of the tangs 185 may extend in the distaldirection at different axial lengths. Each of the tangs 185 arecontrollably positioned upon rotation of the knob 56 to engage a bumpprotrusion 190 disposed along the upper end 114 of the rail 110 of theactuator 90, which is shown in FIG. 12. The bump protrusion 190 isdisposed distal to the interlock stop protrusion 158. The bumpprotrusion 190 may be defined as a second stepped region 192 of therail, where the elevation of second stepped region 192 is above theadjacent stepped region 160 that is proximal to the bump protrusion 190.

In one example, the tangs 185 are disposed along the interior surface194 of the knob body. FIG. 21 shows a slotted or tangless region 200, afirst tang 202, and a second tang 204 longer than the first tang 202,each disposed circumferentially relative to one another along theinterior surface 194 to define three dose setting positions. Thetangless region 200 leads to a first slotted region 201 of the radiallip 152 to permit the actuator 90 to be withdrawn proximally for a full100% fixed dose setting or large dose setting. Without a tang, the bumpprotrusion 190 travels up to the first slotted region 201 to engage thecorresponding section of the radial lip 152. The first tang 202 leads toa second slotted region 203 of the radial lip 152 to permit the actuator90 to be withdrawn proximally to a position less than the full positionfor full 100% fixed dose setting or a medium dose setting. The secondtang 204 leads to a third slotted region 205 of the radial lip 152 topermit the actuator 90 to be withdrawn proximally to a position lessthan the full position for full 100% fixed dose and less than saidposition for the dose setting allowed by the first tang or a small dosesetting. With the first and second tangs 202, 204, the bump protrusion190 engages the respective tangs during withdrawal of the actuator toless than full travel to inhibit full travel through the respectiveslotted regions. In another embodiment, the tangs may be integral with astepped tang that when positioned accordingly provides the varyingdosages.

The length and number of axial tangs may be selected and modified toaccommodate different variable fixed doses. In one embodiment, thelength of the tang corresponds to a number of ratchet teeth. In otherembodiments, the tangs 202, 204 may extend beyond the knob body. Forexample, the dose selector may be positioned for 100% fixed dose, 66%fixed dose and 33% fixed dose. Other percentages may be provided. In oneembodiment, the large dose setting allows for three ratchet teethdistance travel, the medium dose setting allows for two ratchet teethdistance travel, the small dose setting allows for a single ratchetteeth distance travel. To this end, the axial length of the first tangis sized to reduce the 100% dose by one ratchet tooth, and the axiallength of the second tang is sized to reduce the 100% dose by tworatchet teeth.

FIG. 23 illustrates an example of providing a load brake system 210 tothe device 20 to inhibit high loads applied to the actuator 90 fromtransferring into the gear set 62 and the plunger member 64 during dosedelivery that could damage the components of the device. The actuator 90may include a brake pawl 212 having at least one tooth that isengageable with a brake element 214 fixedly disposed in the housing 21to define load brake system 210. The actuator 90 is shown including afirst flex member 220, defining first side 96, and a second flex member224, defining second side 98, extending axially from the button end 94.The first and second flex members 220, 224 are disposed on oppositesides of and in parallel spaced relationship with the rigid guide railelement 110. The flex member 220 includes the brake pawl 212 that isdisposed along the radial interior surface 221 of the member 220 thatfaces the guide rail element 110. The flex member 224 includes the brakepawl 213 that is disposed along the radial interior surface 225 of themember 224 that faces the guide rail element 110. With additionalreference to FIG. 3, brake element 214 is shown as a plurality ofratchet brake teeth disposed longitudinally along the exterior surfaceof one of ribs 116 of housing half 30. Housing 21 may also includeaxially extending ratchet brake teeth 215, shown disposed along theexterior surface of the other of ribs 116 of housing halve 30, forengagement with the brake pawl 213. The brake pawl may be disposedbetween the pin-coupling and the button end 94.

The load force required to drive the piston within the cartridge toexpel medication from the needle can be attributed to the variousfactors of the device, such as the size of the needle cannula, the sizeof the piston, the viscosity of the medication, the lubricant of thesyringe barrel, frictional losses of the drive mechanism, and the like.The initial force to overcome the piston at static is greater than theforce to continue to move the piston during dynamic movement. Devicescan be designed with a predetermined load actuator force requirementduring static and dynamic movement of the piston to inhibit excessiveforces that can cause damage to internal components. The body of each offlex members 220, 224 of actuator 90 is configured to buckle, flexingradially inward from its natural configuration, at a predefined axialforce provided by the user to the actuator 90. Such a load larger thanthis predefined axial force generates a moment (torque) on the flexmembers that causes them to flex. The radial flexing of flex members220, 224 (in the direction of arrows 223, 227 in FIG. 23) places therespective brake pawls 212, 213 in engagement with one of the backsideof the teeth of the corresponding ratchet brake teeth 214, 215 toinhibit any further movement of the actuator 90 relative to the housing.Once the force is reduced, the flex members 220, 224 may have aresiliency to return to its natural configuration (shown in FIG. 23),where the respective brake pawls 212, 213 are disengaged with and clearthe teeth of the corresponding ratchet brake teeth 214, 215 to allowfurther advancement of the actuator. In other embodiments, a single flexmember may be used instead of a pair. In other embodiments, the flexmember may be configured to flex outward or upward to engage the ratchetteeth that can be disposed outward relative to the actuator. When theload is less than the predefined axial force, that is normal loadforces, there is no flexing of the flex members to the degree ofengagement and thus the load brake system may not provide additionalfrictional losses to the drive system under normal loads.

The actuator 90, with or without the flex members 220, 224, may be aunitary piece from the input coupling end to the button end, which mayavoid the assembling of multiple components and use of a spring foractuation load dampening. In another example, the actuator 90, with orwithout the flex members 220, 224, may be manufactured by assemblingseveral components like the flex members 220, 224 in a secured manner toform the unitary piece. In one example, the actuator 90 with the flexmembers 220, 224 and one or more of other features described herein is amoldable unitary part, such as, for example, from an injection moldedplastic process. The actuator 90 with the flex members 220, 224 may bereferred to as a springless actuator, since the load brake functionoccurs without a helical spring arrangement with the actuator.

FIG. 24 depicts the inclusion of a dose detection system 300 within thedevice 20, such that the device 20 can be configured to detect,indicate, display and/or communicate dose injection data to an externaldevice, such as a smartphone or a server. Dose detection systemsdescribed herein use a sensing component 302 and a sensed component 304coupled to members of the medication delivery device. The sensingcomponent 302 may be attached to a member of the device 20 by beingdirectly positioned on, received within, integral with, or otherwiseconnected to, the member. Connections may include, for example,connections formed by frictional engagement, splines, a snap or pressfit, sonic welding or adhesive.

Sensing component 302 refers to any component which is able to detectthe relative position of the sensed component 304. The sensing component302 includes a sensing element, or “sensor”, along with associatedelectrical components to operate the sensing element. Sensed component304 refers to any component for which the sensing component 302 is ableto detect the position and/or movement of the sensed component 304relative to the sensing component 302. For the dose delivery detectionsystem, the sensed component axially translates relative to the sensingcomponent, which is able to detect the longitudinal position and/or thelongitudinal movement of the sensed component, and to provide outputsrepresentative of the position(s) or movement(s) of the sensedcomponent(s). For the dose type detection system 300, the sensingcomponent 302 detects the relative longitudinal position of the sensedcomponent 304. The sensing component 302 may include one or more sensingelements, and the sensed component 304 may comprise one or more sensedelements.

The system 300 is operable to determine different longitudinal positionsof the sensed component and/or total distance of travel. The sensingcomponent 302 produces outputs representative of the position(s) or theamount of movement of the sensed component 304. For example, the sensingcomponent 302 may be operable to generate outputs by which the distancetravel of the dose setting member during dose delivery can bedetermined. System 300 may comprise a processing circuit (not shown)operably connected to the sensing component 302 to receive the outputs.In one aspect, system 300 is configured to determine from the outputsthe amount of dose delivered by operation of the medication deliverydevice.

With the extent of longitudinal distance having a known relationship tothe amount of a delivered dose, the system 300 is operable to detect theamount of longitudinal movement from the start of a dose injection tothe end of the dose injection. For example, a typical relationship for apen injector is that a longitudinal displacement of a plunger is theequivalent of a predetermined amount of units of dose, such as, 1, 2, 3,4, 5, 6, or more, using any incremental units. The system 300 isoperable to determine the total longitudinal displacement of a dosesetting member during dose delivery in order for such data to be used todetermine the dose delivered. An alternative approach is to detect thestart and stop positions of the relatively moving member, and todetermine the amount of delivered dose as the difference between thosepositions. Various methods for this are well within the ordinary skillin the art and may include “counting” the number of increments, that isratchet teeth, to assess the distance travel and thus number of unitsdelivered.

Any of a variety of sensing technologies may be incorporated by whichthe relative positions of two members can be detected. Such technologiesmay include, for example, technologies based on tactile, vibration,optical, inductive, capacitive or electrical measurements. Suchtechnologies may include the measurement of a sensed parameterassociated with a field, such as a magnetic field. In some embodiments,the movement and/or position of the sensed element in the sensed arearelative to the sensing element changes a detectable parameter of thefield, and this change in the detectable parameter may be sensed ormeasured by the sensing element. In such embodiments the sensedparameter may be a capacitance, conductance, resistance, impedance,voltage, inductance, etc. For example, Hall Effect sensors detectchanges in voltage resulting from distortions of an applied magneticfield.

In the example shown, the sensing component 302 is mounted to a part ofthe device housing 21 and the sensed component 304 is defined in acomponent of the dose setting member shown as the plunger member 64. Thesensed component 304 may also comprise the dose setting member, such asthe actuator. The system 300 detects during dose delivery the relativelongitudinal movement of the sensed component 304, and therefore of theplunger member 64, from which is determined the amount of a dosedelivered by the medication delivery device. In an illustrativeembodiment, the sensing component 302 is attached in a rotationally andlongitudinally fixed manner to the device housing 21. In thisembodiment, the sensed component 304 is rotationally and longitudinallyfixed to the dose setting member that is the plunger member 64, whichlongitudinally moves relative to the device body during dose delivery.

Sensing component 302 is shown including an electromechanical switch 320having a trigger arm 322 movable between two or more positions togenerate an electrical output signal to be sent to the processor of amicrocontroller. Sensed component 304 includes a series of sensed teeth330 coupled to the dose setting member. In one example, sensed teeth 330may be defined along a side 331 of the plunger member 64, as shown inFIG. 6. Side 331 may be opposite the non-toothed side 91 of the plungerbody. The sensed teeth 330 can be integrally defined within the bodyside 331 of the plunger member 64. The sensed teeth 330 are shownlongitudinally displaced from one another, spaced from one another bygaps 332. Gaps 332 are sized to receive at least a portion of thetrigger arm 322. The trigger arm 322 may be triggered to a sensingcontact position by movement of the sensed teeth 330 against the triggerarm 322, and, once a sensed tooth passes beyond the trigger arm 322, thetrigger arm 322 is biased to return to a natural, resting position. Onemovement of the trigger arm 322 to its sensing contact position and thenback to its natural resting position may be recognized by the processorof the microcontroller as a single count. Dose detection is achieved bycounting increments (or total number of sensed teeth triggering theswitch) to determine a delivered dose amount. In one example, the system300 may use a repeating pattern of sensed elements, such that eachrepetition is an indication of a predetermined degree of longitudinaldisplacement. Conveniently, the pattern may be established such thateach repetition corresponds to the minimum increment of dose that can beset with the medication delivery device. An alternative approach is todetect the start and stop positions of the relatively moving member, andto determine the amount of delivered dose as the difference betweenthose positions.

FIG. 25 illustrates one example of an electronics assembly 340 of thesystem 300 that can be integrated within the device that is used fordose detection. The electronics assembly 340 may include a printedcircuit board (PCB) 342 having a plurality of electronic components. Theelectronics assembly includes the sensing component, such aselectromechanical switch 320, operatively communicating with a processor350 (shown in FIG. 26) for receiving signals from the sensorrepresentative of the sensed relative longitudinal displacement. Theelectronics assembly further includes the other components, such asshown in FIG. 26. The assembly includes a battery 344, illustratively acoin cell battery, for powering the components. The processor of themicrocontroller includes control logic operative to perform theoperations described herein, including detecting a dose delivered bymedication delivery device based on a detected displacement of the dosesetting member relative to the housing.

The term “logic” or “control logic” or “application” as used herein mayinclude software and/or firmware executing on one or more programmableprocessors, application-specific integrated circuits (ASICs),field-programmable gate arrays (FPGAs), digital signal processors(DSPs), hardwired logic, or combinations thereof. Therefore, inaccordance with the embodiments, various logic may be implemented in anyappropriate fashion and would remain in accordance with the embodimentsherein disclosed.

In FIG. 26, the system 300 includes at least one processor 350 thatexecutes software and/or firmware stored in memory 352 of device 20. Thesoftware/firmware code contains instructions that, when executed byprocessor 350, causes system controller 310 to perform the functionsdescribed herein. The at least one processor 350 illustratively includescontrol logic/application 351 operative to implement the operationsdescribed herein, including detecting a dose delivered by medicationdelivery device based on a detected displacement of the sensed elementrelative to the housing/sensing element. Processor 350 may be operativeto store data indicative of the detected dose amount, time, and otherdata, into memory 352. Memory 352 is any suitable computer readablemedium that is accessible by processor 350. Memory 352 may be a singlestorage device or multiple storage devices, may be located internally orexternally to processor 350, and may include both volatile andnon-volatile media. Exemplary memory 352 includes random-access memory(RAM), read-only memory (ROM), electrically erasable programmable ROM(EEPROM), flash memory, a magnetic storage device, optical disk storage,or any other suitable medium which is configured to store data and whichis accessible by processor 350. The system 300 may include acommunication device 356 that is further operative to wirelesslytransmit and/or receive a signal 358 representative of the detected doseto a paired remote electronic device 360, such as a user's smartphone,over a Bluetooth low energy (BLE) or other suitable short or long rangewireless communication protocol, such as, for example, near-fieldcommunication (NFC), WIFI, or cellular network. Similar to the device20, remote device 360 includes a processor, memory, communicationdevice, and also may include a display for user interface. Remote device360 illustratively includes a mobile device, such as a smartphone.Alternatively, any suitable computing device may be used, including butnot limited to a laptop, desktop, tablet, or server computer, forexample.

As described briefly above, dose detection or sensing systems can beadapted for use in variously configured medication delivery devices. Forexample, dose detection systems may be adapted for use with medicationdelivery devices that include other types of mechanical advantagestructures. More specifically, dose detection systems may be adapted foruse with medication delivery devices that provide a mechanical advantagevia converging ramps, such as any of the devices disclosed in U.S.Patent Application Publication No. 2018/0064882, the disclosure of whichis hereby incorporated by reference in its entirety for all purposes. Asa more specific example and referring to FIG. 27, a medication deliverydevice 400 that includes a dose detection system 402 and provides amechanical advantage via converging ramps is illustrated. Generally, themedication delivery device 400 includes a housing 404 that carries amedication cartridge 406 (which may be, for example, any of themedication cartridges described herein, including the cartridge 48), amechanical advantage-facilitating drive mechanism 408 for delivering oneor more doses of medication from the medication cartridge 406, and thedose detection system 402. The housing 404 includes, for example and asillustrated, a housing front piece 410 and a housing back piece 412 thattogether carry the drive mechanism 408. The housing front piece 410 andthe housing back piece 412 also couple to a cartridge retainer 414 thatremovably carries the medication cartridge 406. The cartridge retainer414 carries a removable cap 416, which is removable by a user tofacilitate delivering one or more doses of the medication from themedication cartridge 406.

With continued reference to FIG. 27, the drive mechanism 408 includes anelongated drive element or plunger member 418 that is translatablydrivable to cause the medication cartridge 406 to deliver one or moredoses of medication therefrom. As illustrated, the plunger member 418may be unidirectionally driven relative to the housing 404. Morespecifically, the plunger member 418 may be drivable in a directiontoward the medication cartridge 406 (that is, in a distal direction) butinhibited from moving in an opposite direction (that is, in a proximaldirection). To facilitate this motion, the plunger member 418 mayinclude a plurality of ratchet teeth 420 that engage pawls 422 of thehousing 404. In addition and as described in further detail below, theplunger member 418 also operatively couples to the dose detection system402.

With further reference to FIG. 27, the drive mechanism 408 also includesa driver or drive element 424 that is translatably carried in thehousing 404. The drive element 424 is configured to unidirectionallydrive the plunger member 418 relative to the housing 404. That is, thedrive element 424 (1) moves together with and drives the plunger member418 distally toward the medication cartridge 406, and (2) translatesproximally relative to the plunger member 418. To facilitate thismotion, the drive element 424 includes pawls (not shown) that engage theratchet teeth 420 of the plunger member 418. The drive element 424 alsoincludes pull surfaces 426, which, as described in further detail below,facilitate driving the drive element 424. The drive element 424 furtherincludes ramp surfaces 428, which, as described in further detail below,facilitate providing a mechanical advantage for delivering one or moredoses of the medication from the medication cartridge 406.

With continued reference to FIG. 27, the drive mechanism 408 furtherincludes an actuator 430 that is movably operable by a user. Theactuator 430 includes two arms 432 that are pivotably coupled at theirproximal ends 434. The actuator arms 432 each include an intermediateglide 436 and a distal glide 438 that are configured to engage the driveelement 424, as described in further detail below.

Referring now to FIGS. 28 and 29, operation of the drive mechanism 408of the medication delivery device 400 is generally described. FIG. 28illustrates the drive mechanism 408 prior to delivering a dose ofmedication. From this position, a user proximally pulls on the proximalends 434 of the actuator arms 432, or in a dose setting direction. Asshown in FIG. 29, the housing 404 forces the actuator arms 432 to pivottoward each other. Upon continued proximal movement of the actuator 430in the dose setting direction (movement not specifically shown), theintermediate glides 436 of the actuator arms 432 engage the pullsurfaces 426 of the drive element 424. The drive element 424 then movesproximally with the actuator 430, and the plunger member 418 remainsstationary relative to the housing 404 (due to the ratchet teeth 420 ofthe plunger member 418 and the pawls 422 of the housing 404 (both shownelsewhere)). From this position, the user then pushes the actuator 430distally, or in a dose delivery direction. This action drives the driveelement 424 distally, albeit over a smaller distance (and, consequently,at a slower rate) because the distal glides 438 of the actuator arms 432slide over the ramp surfaces 428 of the drive element 424. Thisinteraction between the actuator arms 432 and the drive element 424provides a mechanical advantage—that is, the drive element 424 drivesthe plunger member 418 with an increased force (via the pawls of thedrive element 424 (not shown) and the ratchet teeth 420 of the plungermember 418 (shown elsewhere)). Upon continued distal movement of theactuator 430 in the dose delivery direction, the plunger member 418causes the medication cartridge 406 to deliver a dose of medicationtherefrom, and the medication delivery device 400 generally returns tothe position shown in FIG. 28. More specifically, the actuator arms 432and the drive element 424 return to the position shown in FIG. 28,although the plunger member 418 remains distally advanced. Operation maybe repeated to deliver additional doses of medication until themedication cartridge 406 is depleted and/or the plunger member 418reaches an end of its range of motion.

The dose sensing system 402 generally includes a sensing component and asensed component, and the sensing component detects movement of thesensed component to determine the amount of a dose delivered by themedication delivery device 400. As shown in FIG. 27, the sensingcomponent may include an electromechanical switch 440 having a triggerarm 442. The trigger arm 442 may be movable between two or morepositions to generate an electrical actuation signal. Referring to FIGS.30a-30b , the plunger member 418 includes a plurality of sensed teeth444 that form the sensed component. Sensed teeth 444 may be appliedalong an endwall of the side wall of the plunger member, oralternatively, may be disposed along a bottom wall of the cavity definedby the endwalls, similar to how the teeth are disposed in FIGS. 6 and 6a. Generally, the electromechanical switch 440 and the sensed teeth 444,and other components of the dose detection system 402, may be similar tothe components of the dose detection system shown in FIGS. 24-26. Forexample, the trigger arm 442 may be actuated by movement of the sensedteeth 444 against the trigger arm 442 and, after a sensed tooth 444passes beyond the trigger arm 442, the trigger arm 442 is biased toreturn to its initial position. A single actuation and return of thetrigger arm 442 may be recognized by the dose detection system 402 as asingle count. Dose detection may be achieved by counting increments (ora total number of sensed teeth 444 triggering the switch 440) todetermine a delivered dose amount. The delivered dose amount may beindicated, displayed and/or communicated via an external device (notshown), such as a smartphone or a server.

While this invention has been shown and described as having preferreddesigns, the present invention may be modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses or adaptations of the invention using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

Various aspects are described in this disclosure, which include, but arenot limited to, the following aspects:

1. A medication delivery device, including: a housing defined about alongitudinal axis, the housing including one or more housing rack teeth;a plunger having an elongated body with an end to drive a pistondisposed within a medication cartridge barrel, the body including aplurality of ratchet teeth disposed longitudinally spaced from oneanother; a plunger drive system configured to distally advance theplunger, the plunger drive system including an output drive memberhaving one or more pawled ends movably coupled with the ratchet teeth ofthe plunger, the output drive member having one or more drive teeth, atleast one pinion drive engaged with the drive teeth of the output drivemember and the housing rack teeth of the housing, and an actuator havinga coupling end coupled to the at least one pinion drive, the actuatorhaving a unitary piece body extending between a button end and thecoupling end disposed within the housing, the actuator longitudinallymovable between an extended position for dose setting and a retractedposition for dose delivery, wherein, in response to movement of theactuator to the extended position from the retracted position, rotationof the at least one pinion drive in a first direction along the driveteeth is configured to axially translate the output drive memberrelative to the plunger, with the one or more pawled ends of the outputdrive member sliding along the ratchet teeth of the plunger, wherein, inresponse to movement of the actuator to the retracted position from theextended position, rotation of the at least one pinion drive in a seconddirection along the drive teeth is configured to axially translate theoutput drive member, with the one or more pawled ends of the outputdrive member in engagement with the ratchet teeth of the plunger toprevent the output drive member from translating axially relative to theplunger, thereby advancing the plunger in a distal direction.

2. A medication delivery device, including: a housing defined about alongitudinal axis; a plunger having an elongated body with an end todrive a piston disposed within a medication cartridge barrel; a plungerdrive system configured to distally advance the plunger, the plungerdrive system including an actuator longitudinally movable between afully extended position for dose setting and a retracted position fordose delivery; and a rotary dose selector rotatable to a first positionto allow the actuator to move to the fully extended position for a fulldose delivery, and rotatable to another position to place a tang in aposition for engagement with the actuator to inhibit the actuator frommoving to the fully extended position for a partially full dosedelivery.

3. A medication delivery device, including: a housing defined about alongitudinal axis; a plunger having an elongated body with an end todrive a piston disposed within a medication cartridge barrel, the bodyincluding a plurality of ratchet teeth disposed longitudinally spacedfrom one another; a plunger drive system configured to distally advancethe plunger, the plunger drive system including an output drive memberhaving one or more pawled ends movably coupled with the ratchet teeth ofthe plunger, and an actuator longitudinally movable between an extendedposition for dose setting and a retracted position for dose delivery,wherein the output drive member includes a tab, and the plunger definesa longitudinal slot configured to receive the tab, the longitudinal slotdefined at least in part by a proximal lip, wherein, in response tomovement of the actuator to the extended position from the retractedposition during dose setting, the plunger is configured to remainstationary, wherein, in response to movement of the actuator to theretracted position from the extended position during dose delivery, theplunger is configured to distally advance in a distal direction, whereinthe tab is configured to contact the proximal lip of the longitudinalslot during dose setting to prevent relative movement between the outputdrive member and the plunger to indicate the medication delivery deviceis empty of medication.

4. A medication delivery device, including: a housing defined about alongitudinal axis, the housing including one or more housing rack teeth;a linearly displaceable plunger having an elongated body with an end todrive a piston disposed within a medication cartridge barrel, the bodyincluding a plurality of sensed teeth disposed longitudinally spacedfrom one another; a plunger drive system configured to distally advancethe plunger, the plunger drive system including an output member movablycoupled with the plunger, and an actuator having a coupling end coupledto the output drive member, the actuator longitudinally movable betweenan extended position for dose setting and a retracted position for dosedelivery; a dose detection system including an electronics assemblyincluding a switch disposed within the housing to detect the sensedteeth during movement of the plunger, a processor in communication withthe switch and configured to receive a position signal based on a numberof times one of the plurality of sensed teeth contacts the switch,wherein, in response to movement of the actuator to the extendedposition from the retracted position, the output drive member isconfigured to move relative to the plunger to a set position along theplunger, and wherein, in response to movement of the actuator to theretracted position from the extended position, the output drive memberis configured to distally advance the plunger relative to the housing ina distal direction.

5. The device of any one of the preceding aspects, where the deviceincludes a medication.

6. The device of any one of the preceding aspects, wherein a surface ofthe actuator is slidably engaged along a surface of the output drivemember.

7. The device of any one of the preceding aspects, wherein one of theactuator or the output drive member includes a guide element, and theother of the actuator or the output drive member includes a rail elementin slidable contact with the guide element.

8. The device of aspect 7, wherein the actuator includes the railelement, and the output drive member includes the guide element.

9. The device of aspect 8, wherein the guide element includes a pair ofaxially extending parallel guide ribs extending along the output drivemember, and a lower surface of actuator defines the rail element that issized to fit within a space defined by the guide ribs.

10. The device of aspect 9, wherein the actuator includes a lateralshelf extending laterally from one or both sides of the actuator, thelateral shelf disposed in between an upper surface and a lower surfaceof the actuator and is in sliding contact with an upper surface of theguide ribs.

11. The device of any one of the preceding aspects, wherein the at leastone pinion drive includes a first pinion drive and a second pinion drivedisposed along opposite sides of the output drive member, wherein thedrive teeth includes a first rack and a second rack defined by theoutput drive member, wherein the first pinion drive member is engagedwith the first rack, and the second pinion drive member is engaged withthe second rack.

12. The device of aspect 11, wherein the actuator includes a first slotreceiving a pin of the first pinion drive member, and a second slotreceiving a pin of the second pinion drive member.

13. The device of any one of the preceding aspects, wherein the outputdrive member is defined by a U-shaped body to define a plunger memberreceiving passage receiving the plunger, wherein the U-shaped bodyincludes a pair of parallel sides interconnected by a third side,wherein each of the parallel sides include one of the pawled end.

14. The device of aspect 13, wherein the third side of the U-shaped bodyincludes a tab, wherein the plunger defines a longitudinal slotconfigured to receive the tab, the longitudinal slot defined by aproximal lip configured to contact the tab to prevent further relativemovement between the output drive member and the plunger when thedelivery device is empty of medication.

15. The device of any one of the preceding aspects further including aload brake pawl and teeth mechanism configured to inhibit movement ofthe actuator when an input force to the actuator is greater than apredetermined force.

16. The device of aspect 15, wherein the load brake pawl and teethmechanism includes a flexible brake element located between the buttonend and coupling end, that is radially movable to engage a brake elementdefined by the housing when the input force is greater than thepredetermined force.

17. The device of aspect 16, wherein the actuator includes the flexiblebrake element having a brake pawl configured to engage a brake tooth ofthe brake element.

18. The device of aspect 16, wherein the actuator includes a firstflexible brake element and a second flexible brake element coupled toand disposed along opposite sides of a rigid body element of theactuator between the button end and the coupling end, the housingincludes a first brake element and a second brake element, each of thefirst and second brake elements including a plurality of ratchet braketeeth, wherein, in response to the input force to the actuator beinggreater than the predetermined force, the first and second flexiblebrake elements radially flex inwardly to engage the ratchet brake teethof the corresponding first and second brake elements to inhibit furtherdistal movement of the actuator, wherein, in response to the input forceto the actuator being less than the predetermined force, the first andsecond flexible brake elements have a natural configuration to clear theratchet brake teeth of the corresponding first and second brake elementsto allow for further distal movement of the actuator.

19. The device of any one of the preceding aspects, wherein the extendedposition of the actuator includes a fully extended position for a fulldose setting, and the device further including a dose selector to allowthe actuator to move to a dose set position that is less than the fullyextended position.

20. The device of aspect 19, wherein the dose selector includes at leastone axially extending tang that is selectively movable to engage a bumpprotrusion disposed along the actuator.

21. The device of aspect 20, wherein the dose selector includes a doseknob having an interior surface that includes the at least one axiallyextending tang, the dose knob being rotatable to selectively engage thebump protrusion with the at least one axially extending tang, the bumpprotrusion disposed along an upper surface of the actuator.

22. The device of any one of the preceding aspects further including adose detection sensor system configured to detect a dose delivery.

23. The device of aspect 22, wherein the dose detection sensor systemincludes a plurality of sensed teeth defined by the plunger, and ameasurement sensor coupled to the housing and configured to detect inincrements the sensed teeth during movement of the plunger.

24. The device of aspect 23, wherein the dose detection sensor systemincludes a processor in communication with the measurement sensorincluding an electromechanical switch, and configured to receive aposition signal indicative of each time one of the plurality of sensedteeth contacts the electromechanical switch.

25. The device of any one of the preceding aspects, wherein the plungerdrive system includes a pinion drive element configured to be driven bythe actuator, the pinion drive element coupled to the output drivemember via a coupling means to allow transfer of force from the actuatorto the output drive member.

26. A medication delivery device configured to carry a medicationcartridge, the medication cartridge carrying a medication, themedication delivery device including: a housing configured to carry themedication cartridge; an actuator carried by the housing, the actuatorbeing movable relative to the housing in a dose setting direction and anopposite dose delivery direction; a drive element carried by thehousing, the drive element being movable relative to the housing in afirst direction and a second direction, the second direction beingopposite the first direction; a mechanical advantage structure couplingthe actuator to the drive element, the mechanical advantage structurebeing configured such that (1) upon application of a first force to theactuator to move the actuator in the dose delivery direction, the driveelement moves in the first direction with a second force, the secondforce being greater than the first force, and (2) upon movement of theactuator in the dose setting direction, the drive element moves in thesecond direction; a plunger member carried by the housing, the plungermember being movable relative to the housing in the first direction, andthe plunger member being driven in the first direction upon movement ofthe drive element in the first direction to cause the medicationcartridge to deliver a dose of the medication therefrom; and a dosedetection system configured to detect delivery of the dose of themedication from the medication cartridge.

27. The device of aspect 26, wherein the dose detection system detectsat least one of a position and movement of the plunger member to therebydetect delivery of the dose of the medication from the medicationcartridge.

28. The device of aspect 27, wherein the dose detection system includesa plurality of teeth carried by the plunger member and a sensor carriedby the housing, the sensor configured to detect the plurality of teeth.

29. The device of aspect 28, wherein the sensor includes a switchconfigured to engage and be actuated by the plurality of teeth, and theswitch configured to send a signal when one of the plurality of teethactuates the switch.

30. The device of aspect 29, wherein the plunger member is elongated ina longitudinal direction substantially parallel to the first directionand the second direction, and the plurality of teeth are spaced apart inthe longitudinal direction.

I claim:
 1. A medication delivery device, comprising: a housing definedabout a longitudinal axis; a medication cartridge comprising a pistondisposed therein; a plunger having an elongated body with an end todrive the piston within the medication cartridge, the elongated bodyincluding a plurality of ratchet teeth disposed longitudinally spacedfrom one another; a plunger drive system configured to distally advancethe plunger, the plunger drive system including an output drive memberhaving one or more pawled ends movably coupled with the ratchet teeth ofthe plunger, at least one pinion drive operably engaged between theoutput drive member and the housing, and an actuator having a couplingend coupled to the at least one pinion drive and a button end, theactuator longitudinally movable between an extended position and aretracted position, the actuator comprising a bump protrusion; and adose selector configured to allow the actuator to move to a lesser doseset position that is less than the extended position that defines a fulldose setting, wherein the dose selector comprises at least one axialtang, wherein the dose selector is rotatable to a first position toallow the actuator to move to the extended position that defines thefull dose setting and a second position to allow the actuator to move tothe lesser dose set position in response to engagement between the atleast one axial tang and the bump protrusion of the actuator, wherein,in response to movement of the actuator to the extended position or thelesser dose set position from the retracted position, rotation of the atleast one pinion drive is in a first direction to axially translate theoutput drive member relative to the plunger, with the one or more pawledends of the output drive member sliding along the ratchet teeth of theplunger, wherein, in response to movement of the actuator to theretracted position from the extended position, rotation of the at leastone pinion drive is in a second direction to axially translate theoutput drive member, with the one or more pawled ends of the outputdrive member in engagement with the ratchet teeth of said plunger,thereby advancing the plunger in a distal direction.
 2. The device ofclaim 1, wherein a surface of the actuator is slidably engaged along asurface of the output drive member.
 3. The device of claim 1, whereinone of the actuator or the output drive member includes a guide element,and the other of the actuator or the output drive member includes a railelement in slidable contact with the guide element.
 4. The device ofclaim 3, wherein the actuator includes said rail element, and the outputdrive member includes said guide element.
 5. The device of claim 1,wherein the at least one pinion drive includes a first pinion drive anda second pinion drive disposed along opposite sides of the output drivemember, wherein the output drive member includes a first rack and asecond rack, wherein the first pinion drive is engaged with the firstrack, and the second pinion drive is engaged with the second rack. 6.The device of claim 5, wherein the actuator includes a first slotreceiving a pin of the first pinion drive, and a second slot receiving apin of the second pinion drive.
 7. The device of claim 1, wherein theoutput drive member is defined by a U-shaped body to define a plungermember receiving passage receiving the plunger, wherein the U-shapedbody includes a pair of parallel sides interconnected by a third side.8. The device of claim 7, wherein said third side of said U-shaped bodyincludes a tab, wherein the plunger defines a longitudinal slotconfigured to receive said tab, the longitudinal slot defined by aproximal lip configured to contact the tab to prevent further relativemovement between the output drive member and the plunger when thedelivery device is empty of medication.
 9. The device of claim 1,wherein the dose selector comprises a dose knob having an interiorsurface that includes said at least one axially extending tang and atangless region.
 10. The device of claim 9, wherein said at least oneaxially extending tang comprises a first tang having a length sized tocorrespond to a travel distance of one ratchet teeth less than a numberof ratchet teeth for the full dose setting.
 11. The device of claim 10,wherein said at least one axially extending tang comprises a second tanghaving a length sized to correspond to a travel distance of two ratchetteeth less than the number of ratchet teeth for the full dose setting.12. The device of claim 9 wherein the dose knob includes an internal liphaving a locking region, wherein when the dose knob is at a lockedposition, the locking region of the internal lip is configured tophysically block the actuator from moving to the extended position. 13.The device of claim 1 further comprising a load brake pawl and teethmechanism configured to inhibit movement of the actuator when an inputforce to the actuator is greater than a predetermined force.
 14. Thedevice of claim 13, wherein the load brake pawl and teeth mechanismincludes a flexible brake element located between the button end and thecoupling end, that is radially movable to engage a brake element definedby the housing when the input force is greater than the predeterminedforce.
 15. The device of claim 1, further comprising a dose detectionsensor system that includes a plurality of sensed teeth defined by theplunger, and a measurement sensor coupled to the housing and configuredto detect in increments the sensed teeth during movement of the plungerduring dose delivery.
 16. The device of claim 15, wherein the dosedetection sensor system includes a processor in communication with themeasurement sensor comprising an electromechanical switch, andconfigured to receive a position signal indicative of each time one ofthe plurality of sensed teeth contacts the electromechanical switch. 17.The device of claim 1, wherein the medication cartridge contains amedication.
 18. A method of delivering a medication, comprising: movingan actuator of a medication delivery device longitudinally to anextended position from a retracted position, thereby causing rotation ofat least one pinion drive is in a first direction which axiallytranslates an output drive member relative to a plunger, with one ormore pawled ends of the output drive member sliding along ratchet teethof the plunger, the medication delivery device comprising a housingdefined about a longitudinal axis, a medication cartridge holing amedication and comprising a piston disposed therein and an outlet, theplunger having an elongated body with an end to drive the piston withinthe medication cartridge, the elongated body including a plurality ofratchet teeth disposed longitudinally spaced from one another, the atleast one pinion drive operably engaged between the output drive memberand the housing, the actuator having a coupling end coupled to the atleast one pinion drive and a button end, moving the actuatorlongitudinally to the retracted position from the extended position,thereby causing rotation of the at least one pinion drive is in a seconddirection which axially translates the output drive member, with the oneor more pawled ends of the output drive member in engagement with theratchet teeth of said plunger for advancing the plunger and thus thepiston in a distal direction to expel the medication from the outlet.19. The method of claim 18, wherein the actuator includes a bumpprotrusion, and the device includes a dose selector configured to allowthe actuator to move to a lesser dose set position that is less than theextended position that defines a full dose setting, wherein the doseselector comprises at least one axial tang, the method furthercomprising: prior to the moving the actuator to the extended positionstep, rotating the dose selector to a first position to allow theactuator to move to the extended position that defines the full dosesetting or to a second position to allow the actuator to move to thelesser dose set position in response to engagement between the at leastone axial tang and the bump protrusion of the actuator.
 20. The methodof claim 18, further comprising: braking the movement of the actuator tothe retracted position when the input force to the actuator is greaterthan the predetermined force.